Heart Failure Clinical Trial

Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will:

decrease the number of hospital and clinic visits due to heart failure symptoms
extend life
delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines
Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked
Subject is receiving first time implant
Subjects with heart failure but no symptoms of it (New York Heart Association [NYHA] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III)
Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days
Subject is at least 18 years old
Subject or authorized legal guardian or representative has signed and dated the Informed Consent
Subject is able to receive a pectoral implant
Subject is expected to remain available for follow-up visits at the study center
Subject is willing and able to comply with the protocol

Exclusion Criteria:

Subject has ever had a previous or has an existing device implant
Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days
Subjects with coronary bypass within the past 30 days
Subjects with stent within the past 30 days
Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement
Subjects with a mechanical right heart valve
Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices)
Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager)
Subject is pregnant, or of child bearing potential and not on a reliable form of birth control
Subjects with a previous heart transplant
Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting)
Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

Study is for people with:

Heart Failure

Estimated Enrollment:

918

Study ID:

NCT00267098

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There is 1 Location for this study

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Anchorage Alaska, , United States

Peoria Arizona, , United States

Little Rock Arkansas, , United States

Glendale California, , United States

Long Beach California, , United States

Colorado Springs Colorado, , United States

Hollywood Florida, , United States

Jacksonville Florida, , United States

Pensacola Florida, , United States

Tampa Florida, , United States

Park Ridge Illinois, , United States

Rockford Illinois, , United States

Davenport Iowa, , United States

Lexington Kentucky, , United States

Lacombe Louisiana, , United States

Boston Massachusetts, , United States

Grand Rapids Michigan, , United States

Petoskey Michigan, , United States

Ypsilanti Michigan, , United States

Minneapolis Minnesota, , United States

St. Louis Park Minnesota, , United States

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St. Louis Missouri, , United States

Lincoln Nebraska, , United States

Camden New Jersey, , United States

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Tulsa Oklahoma, , United States

Danville Pennsylvania, , United States

Doylestown Pennsylvania, , United States

Ephrata Pennsylvania, , United States

Lancaster Pennsylvania, , United States

Philadelphia Pennsylvania, , United States

Wynnewood Pennsylvania, , United States

Wyomissing Pennsylvania, , United States

Providence Rhode Island, , United States

Kingsport Tennessee, , United States

Dallas Texas, , United States

Fort Worth Texas, , United States

Fairfax Virginia, , United States

Norfolk Virginia, , United States

Spokane Washington, , United States

Morgantown West Virginia, , United States

Milwaukee Wisconsin, , United States

Kitchener Ontario, , Canada

Toronto Ontario, , Canada

Montreal Quebec, , Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

918

Study ID:

NCT00267098

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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